🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

  • ✅ Early warning system for potential safety signals
  • ✅ Open and transparent - publicly accessible
  • ✅ Accepts all reports regardless of likelihood of causation
  • ✅ Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2830670 78 M IA 03/11/2025 COVID19
 MODERNA
Death Death
Death Death
✓
2830671 34 M VA 03/11/2025 FLU3
MMR
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 CZ47E
Y005808
Oedema peripheral, Tenderness; Oedema peripheral, Tenderness Oedema peripheral, Tenderness; Oedema peripheral, Tenderness
Patient noted swelling under left arm pit around 9:00 am on 3/11/25. Stated it is tender and bulging... Patient noted swelling under left arm pit around 9:00 am on 3/11/25. Stated it is tender and bulging. No other symptoms noted per patient. More
2830672 56 F MO 03/11/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 G97Y2
G97Y2
Erythema, Induration, Peripheral swelling, Pyrexia; Erythema, Induration, Periph... Erythema, Induration, Peripheral swelling, Pyrexia; Erythema, Induration, Peripheral swelling, Pyrexia More
Swelling in left arm, redness, fever, and knot formed about 2 hours after vaccine Swelling in left arm, redness, fever, and knot formed about 2 hours after vaccine
2830673 0.5 F NY 03/11/2025 RV5
 MERCK & CO. INC.
 2096657
Diarrhoea, Ultrasound kidney normal, Vomiting Diarrhoea, Ultrasound kidney normal, Vomiting
Vomiting and diarrhea the day after immunizations. Needed to go to ED. Unclear if it is vaccine re... Vomiting and diarrhea the day after immunizations. Needed to go to ED. Unclear if it is vaccine related or a GI bug. Parents requesting VAERS completed. More
2830674 33 F NC 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Contusion, Headache, Pyrexia Chills, Contusion, Headache, Pyrexia
Bruising within 12 hours fever chills and headache within 24 hours Bruising within 12 hours fever chills and headache within 24 hours
2830675 70 F CA 03/11/2025 RSV
 PFIZER\WYETH
Arthralgia, Induration Arthralgia, Induration
INJECTION SITE-UPPER LEFT ARM. SMALL KNOT FORMED AT BASE OF INNER LEFT WRIST (3 OUT OF 10 PAIN) CLOS... INJECTION SITE-UPPER LEFT ARM. SMALL KNOT FORMED AT BASE OF INNER LEFT WRIST (3 OUT OF 10 PAIN) CLOSE TO BOTTOM OF PALM. NOTICED ON 03/08/25. More
2830676 10 F OH 03/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 Y5aj9
Expired product administered Expired product administered
Vaccine was given on 3/11/2025 but it expired on 3/3/2025. Does child need to be re vaccinated? Vaccine was given on 3/11/2025 but it expired on 3/3/2025. Does child need to be re vaccinated?
2830677 28 M CA 03/11/2025 COVID19
 JANSSEN
 201A21A
End stage renal disease, Immune system disorder End stage renal disease, Immune system disorder
My dad and I both received the Janssen vaccine for our first COVID shot and later got the Pfizer vac... My dad and I both received the Janssen vaccine for our first COVID shot and later got the Pfizer vaccine on January 5, 2022. My dad has type 2 diabetes. After the vaccination, he began experiencing joint pain. Later, when he returned to country and underwent a physical checkup, he was diagnosed with an immune system disease that was causing all his symptoms. He is still receiving treatment for it now. In January 2025, I was diagnosed with stage 5 kidney failure, also due to an immune system disorder attacking my own body. I was perfectly healthy last year, and there?s no history of these issues in my family. My grandparents and their siblings all lived past 90. I suspect the vaccine may have altered my immune system response. More
✓ ✓
2830678 45 F FL 03/11/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 943193
Arthralgia, Injection site pain, Pain, Pain in extremity Arthralgia, Injection site pain, Pain, Pain in extremity
Pt stated that her arm was fine, maybe a little sore as expected after a vaccine. Then, approximatel... Pt stated that her arm was fine, maybe a little sore as expected after a vaccine. Then, approximately 1 month later, she was getting pain at injections site. She experienced shoulder pain only when lifting her arm up forward (like when driving). It still aches till now, roughly 8 months later. More
2830680 2 M WA 03/11/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 D252F
Wrong product administered Wrong product administered
Incorrect Immunization given. The patient was given a DTAP/HEPB/IPV combined vaccine instead of a DT... Incorrect Immunization given. The patient was given a DTAP/HEPB/IPV combined vaccine instead of a DTAP. More
2830681 15 F FL 03/11/2025 HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 NE 01680
NE 01680
NE 01680
Brain fog, Computerised tomogram head normal, Concussion, Confusional state, Dis... Brain fog, Computerised tomogram head normal, Concussion, Confusional state, Disturbance in attention; Dizziness, Dizziness postural, Headache, Hyperacusis, Injury; Loss of personal independence in daily activities, Nausea, Syncope, Vision blurred More
Dizziness, Faint (syncope) upon standing. Blurred vision, nausea. Observation by nurse extended 40 m... Dizziness, Faint (syncope) upon standing. Blurred vision, nausea. Observation by nurse extended 40 minutes after vaccination. 7/20/2007 Complained of continued dizziness/lightheadedness when sitting up or standing up to quickly. 7/30/2007 Complained of faintness when walking from bedroom to toilet. Unable to focus, unable to concentrate, Headache, confusion prior to Full Syncope episode with injury. Stayed home from school. 8/2/2007 Back to School. First period Math, " That's when I couldn't concentrate. Dizzy, felt like vision was blurry, felt nauseous and felt like I could hear every talking around me and couldn't focus on the teacher talking. Like it felt very loud in the room." School called mom. August 2, 2007 MD office visit who ordered CT of Brain for on going HA and confusion (difficulty concentrating and brain fog). Gardasil Vaccine of Merck Co. Inc. was approved for use in 2006. Starting in April 2007 the provided HPV vaccine free to girls aged 12-17 years through the National HPV vaccine program in a school based program. More
✓
2830682 15 F FL 03/11/2025 HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
 J2926
J2926
Dizziness, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual clots, Nausea; Syn... Dizziness, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual clots, Nausea; Syncope, Vision blurred More
Dizziness, Faint (syncope) upon standing. Blurred Vision, nausea. Observation by Nurse extended to 4... Dizziness, Faint (syncope) upon standing. Blurred Vision, nausea. Observation by Nurse extended to 40 minutes. November 2007, First Menstrual period one month after vaccine. Patient claims severe cramping with very heavy flow (bleeding/clotting) for first 3 days, changing pads every 1-2 hours. Would bleed through to pants. Period would last 5-7 days. More
2830683 16 F FL 03/11/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 J2926
J2926
J2926
J2926
J2926
J2926
J2926
J2926
J2926
Abdominal pain upper, Abnormal uterine bleeding, Arrhythmia, Arthralgia, Bradyca... Abdominal pain upper, Abnormal uterine bleeding, Arrhythmia, Arthralgia, Bradycardia; Chest pain, Diarrhoea, Dizziness, Dizziness postural, Dysmenorrhoea; Dyspnoea, Dysstasia, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Extrasystoles; Fatigue, Gastritis, Heavy menstrual bleeding, Human papilloma virus test positive, Hyperhidrosis; Hypotension, Insomnia, Irritable bowel syndrome, Loss of personal independence in daily activities, Menstrual clots; Menstruation irregular, Mobility decreased, Myocardial infarction, Nausea, Orthostatic intolerance; Palpitations, Postural orthostatic tachycardia syndrome, Rash, Sinus arrhythmia, Sleep study abnormal; Supraventricular tachycardia, Syncope, Tachycardia, Tilt table test positive, Troponin I increased; Urticaria, Uterine spasm, Ventricular extrasystoles, Vision blurred More
Dizziness, Faint (syncope) upon standing. Blurred Vision, nausea. Observation by Nurse extended 40 m... Dizziness, Faint (syncope) upon standing. Blurred Vision, nausea. Observation by Nurse extended 40 minutes. During 2008-2009 Developed Severe Abdominal Pain in Epigastric Region, Etiology Undeterminded. Patient would remain in bed curled up in a fetal position unable to stand or move or go to school. She was seen many times at medical facilities, Urgent Care Clinics, and hospitals. She was placed on Prilosec and narcotics. Menstrual bleeding/clotting and uterine cramping progressively worsened to "Cramps so bad that I couldn't stand up straight". Menstruation began occurring more often, every two weeks. Patient was placed on birth control for erratic painful menses. 2008-present diag Medical Diagnosis with ICD-10 codes and MD progressive notes per patient's medical records 2008-present: Severe Abdominal Pain, Epigastric Region [789.00] [R10.9] [789.06] [R10.13]. Menorrhagia-profound Heavy Bleeding with clots. Dysmenorrhea. Irregular every 2 weeks. Dysfunction Uterine Bleeding (DUB). Later diagnosed with Irritable Bowel Syndrome (IBS) [564.1] [K58.9] [K58.0]; Acute Gastritis [V12.70] [Z87.19]. Diarrhea [787.9] [R19.7] HPV Detected in Pap Smear; vaginal; cervical. Neurogenic Syncope [780] [R55]; Vasodepressive Pattern of Syncopal episodes. Tilt Table Study: Abnormal Head Tilt: Full Syncope with 70 degree tilt. Postural Orthostatic Tachycardia Syndrome (POTS) [G90.A]. Extreme Fatigue; Hypotension [195.0] [195.1]; Light Headedness; Dizziness; SOB; Excessive Sweating. Shortness of Breath (SOB); Chest Pain [786.50] [R07.9]; Heart Palpitations [785.1] [R00.2]. 24H Holter: Bradycardia 33-40 BPM; Fast Resting Heart Rate 155 BPM; Missed Beat. Elevated Troponin 1 [790.6] [R74.8] [R79.89]. Heart Attack. 12 Lead ECG: Sinus Arrhythmia, Probable Anteroseptal Infarct, age undetermined. Sleep Study/24H Holter: Arrhythmia Heart Rate; Ventricular Ectopic activity-2 episodes; Supraventricular activity-418 episodes. Bradycardia 33-40 BPM-862 episodes. Tachycardia 145 BPM while sleeping 2:25am. Urticarial Rash; Face and Neck following fainting episode from head tilt in Piaties Class. Excessive Sweating. Chronic Joint Pain. Insomnia and Orthostatic Intolerance. Prior to the Gardasil HPV vaccinations, all of patient's annual primary care physician visits were normal. Patient was also a competitive Rock Climber and an active Snowboarder. Merck Co. Inc.'s own clinical studies now show that Gardasil Vaccine was a risk for neurological disorders and autoimmune diseases, particularly a form of Dysautonomia known as POTS- Postural Orthostatic Tachycardia Syndrome. Gardasil's link to autoimmune injuries take time to manifest and therefore can take 5-8 years before a formal autoimmune injury diagnosis is made. More
✓
2830684 70 F FL 03/11/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 013M20A
013M20A
013M20A
006B21A
006B21A
006B21A
035C21A
035C21A
035C21A
021H22A
021H22A
021H22A
Cardiac pacemaker insertion, Chest X-ray, Chills, Dyspnoea exertional, Echocardi... Cardiac pacemaker insertion, Chest X-ray, Chills, Dyspnoea exertional, Echocardiogram; Electrocardiogram, Erythema, Headache, Pain in extremity, Peripheral swelling; Skin warm, Ultrasound scan; Cardiac pacemaker insertion, Chest X-ray, Chills, Dyspnoea exertional, Echocardiogram; Electrocardiogram, Erythema, Headache, Pain in extremity, Peripheral swelling; Skin warm, Ultrasound scan; Cardiac pacemaker insertion, Chest X-ray, Chills, Dyspnoea exertional, Echocardiogram; Electrocardiogram, Erythema, Headache, Pain in extremity, Peripheral swelling; Skin warm, Ultrasound scan; Cardiac pacemaker insertion, Chest X-ray, Chills, Dyspnoea exertional, Echocardiogram; Electrocardiogram, Erythema, Headache, Pain in extremity, Peripheral swelling; Skin warm, Ultrasound scan More
Each time I received a vaccine my left arm would become swollen, sore, warm and red to the touch. I ... Each time I received a vaccine my left arm would become swollen, sore, warm and red to the touch. I would also get a headache and chills. i noticed that I became short of breath whenever I did chores around the home or when I went for a walk to the point that I had to stop and rest. I went in to see my Primary Doctor who referred my to see cardiologist Dr. I saw Dr on 01/18/2022 and she immediately scheduled me for surgery the next day 01/19/2022 to implant a pacemaker at Medical Center. More
✓ ✓
2830685 30 F NJ 03/11/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 DG3TN
PG52S
Exposure during pregnancy, Extra dose administered, No adverse event; Exposure d... Exposure during pregnancy, Extra dose administered, No adverse event; Exposure during pregnancy, Extra dose administered, No adverse event More
Patient received dose of flu vaccine during her pregnancy. No adverse reactions noted after vaccinat... Patient received dose of flu vaccine during her pregnancy. No adverse reactions noted after vaccination. Patient was seen by internal medicine on 2/25/25 and received a duplicate dose of the flu vaccine (Fluarix). There were no adverse reactions at the time of the second vaccine. The patient was not pregnant during the second vaccination. Patient verbalized she did not receive the flu vaccine when speaking with the provider, but the medical record does show two. one on the indicated 10/18/24 date and one on the 2/25/25 date. More
2830686 0.5 F PA 03/11/2025 DTAPIPV
HEP
PNC20
RV5
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 U8198AA
42D7A
LG5575
X28576
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Provider ordered Quadracel instead of Pentacel. Quadracel was administered. Previous two doses were ... Provider ordered Quadracel instead of Pentacel. Quadracel was administered. Previous two doses were Pentacel dose on 03/10/25 was Quadracel which is incorrect for patient's age. More
2830687 76 F CA 03/11/2025 HEP
 MERCK & CO. INC.
 Y014323
Dyspnoea, Headache, Musculoskeletal chest pain, Nervousness, Throat tightness Dyspnoea, Headache, Musculoskeletal chest pain, Nervousness, Throat tightness
Patient reports feeling very shaky and head felt "ponding" . Rib cage felt "open"... Patient reports feeling very shaky and head felt "ponding" . Rib cage felt "open" and a sharp pain was severe. Denies shortness of breath. Chest pain was severe. Esophagus felt tight. More
2830688 75 F CA 03/11/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Abdominal pain upper, Aspiration, Death, Posture abnormal, Resuscitation; Unresp... Abdominal pain upper, Aspiration, Death, Posture abnormal, Resuscitation; Unresponsive to stimuli, Vomiting More
pts daughter says they came home and ate some fried potatoes. She went to take a nap. She woke up fr... pts daughter says they came home and ate some fried potatoes. She went to take a nap. She woke up from her nap complaining of her stomach hurting. She started throwing up. She took Tums plus gas relief. Her daughter gave her a gas pill but she is not sure if she took it or not. She stayed in the bathroom a long time so her daughter thinks she had diarrhea. When dinner time came around, she didn't want to join them, so she stayed in bed. Her daughter wanted to take her to the hospital but she declined wanting to go. She checked on her around 930 and she was sleeping. She woke her up and she told her daughter she just wanted to sleep. She checked on her again about 11 pm and she was asleep. She woke her up again. She was responsive. She checked on her again the next morning at 7 am where she found her slumped over in her chair. She had aspiration coming out of her mouth around her nose up to her eyes unresponsive. She call EMS and then started CPR. EMS took over but it was unsuccessful. She would like an autopsy to see if the vaccine is why she passed away. More
✓
2830689 49 F IN 03/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 Mc7hk
Chest X-ray, Nodule Chest X-ray, Nodule
3 days after the administration of the Tap vaccine, the patient reported a nodule/lump to R collar b... 3 days after the administration of the Tap vaccine, the patient reported a nodule/lump to R collar bone. It was free moving, and reports about a size of a quarter, and was painful. The patient saw her physician and he believed it was related to her recent vaccination. He ordered a chest-x-ray . More
2830690 43 F CA 03/11/2025 PNC20
 PFIZER\WYETH
 LX2497
Injection site erythema, Injection site pruritus, Injection site warmth Injection site erythema, Injection site pruritus, Injection site warmth
INJECTION SITE REDNESS, WARM TO TOUCH AND ITCHING INJECTION SITE REDNESS, WARM TO TOUCH AND ITCHING
2830691 11 M CA 03/11/2025 FLU3
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 AE2J7
X019107
Y007955
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient given MMR, Varicella and Flu vaccine instead of the ordered HPV vaccine. Patient was monito... Patient given MMR, Varicella and Flu vaccine instead of the ordered HPV vaccine. Patient was monitored for 30 minutes after receiving vaccines. No symptoms noted. More
2830692 75 F SC 03/11/2025 COVID19
 MODERNA
 8081596
Erythema, Induration, Skin warm Erythema, Induration, Skin warm
pt called 1 month after vaccine and stated that she had a hard knot and it was red and warm to the ... pt called 1 month after vaccine and stated that she had a hard knot and it was red and warm to the touch-- only lasted a couple days More
2830693 0.33 F MO 03/11/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
WE INADVERTANTLY GAVE THIS VACCINE TODAY THAT EXPIRED ON 2/26/27. WE INADVERTANTLY GAVE THIS VACCINE TODAY THAT EXPIRED ON 2/26/27.
2830694 4 M NC 03/11/2025 RAB
TYP
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 ARBB101A
X2A421M?21120G4
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient's mother called on 3/3/25 to let this RN know that the patient had gone to an outside t... Patient's mother called on 3/3/25 to let this RN know that the patient had gone to an outside travel clinic last week and received the typhoid vaccine at their site so no typhoid vaccine needed at patient's 3/5/25 Nurse visit appointment. RN added comment in nurse appointment notes, talked with Team Lead on 3/3 and asked them to pass along information to nurse for 3/5 visit and spoke with pharmacy to let them know vaccine would not be needed. Messages were not conveyed to nurse administering vaccine. Second typhoid vaccine given to patient on 3/5/25. RN learned of this occurrence on 3/7/25 when patient's mother called and reported it to this RN. No adverse reactions noted by mother. Patient feeling fine and at school on 3/7/25 when she called. More
2830695 78 F VA 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3331y
Injection site rash, Rash, Rash erythematous Injection site rash, Rash, Rash erythematous
Patient received her first Shingrix vaccine Friday morning and noticed a red rash on the arm she had... Patient received her first Shingrix vaccine Friday morning and noticed a red rash on the arm she had the vaccine on roughly 36 hours from the time of vaccination. She presented herself to the pharmacy Monday morning after being recommended to do so by her coworkers. The rash is roughly 5 inches in length, 2 inches in width, and centered 4 inches down from the vaccination site, though on the inside of her arm and not by the vaccination site. Patient notes that it is not painful, but is sore/tender and radiates a lot of heat. I recommended trying some Benedryl and see if the rash dissipates after 12-24 hours, but due to financial constraints she is unable to buy some, so I recommended using the Tylenol she has at home, though I warned it may not be as helpful as the Benadryl would be. I advised patient to let her doctor and I know if the rash does not start shrinking within 24-48 hours of when she starts the Tylenol. As of 4:00 pm Tuesday, no word has been heard back from patient. More
2830696 75 F KS 03/11/2025 FLU3
RSV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 ut8437ca
g22gh
Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
Patient reported to the pharmacy on 3/11/25 stating that when she got shot on 01/10/25, her right ar... Patient reported to the pharmacy on 3/11/25 stating that when she got shot on 01/10/25, her right arm hurt afterwards and still hurts. She says that they must have hit a nerve in her arm. She says she is in physical therapy now and is not sure if it is helping. More
2830697 15 F CT 03/11/2025 IPV
 SANOFI PASTEUR
Abdominal pain Abdominal pain
I prescribed Vivotif and she took on Sun night. Mon morning, the next day, she woke up with severe ... I prescribed Vivotif and she took on Sun night. Mon morning, the next day, she woke up with severe abd pain. No other symptoms. Symptoms dissipated after 12 hours. She has taken Vivotif without an issue before. I sent the prescription to the phamracy so I do not have the lot information. She came to our clinic a week later and had the inactived typhoid vaccine. More
2830698 4 F OK 03/11/2025 DTAPIPVHIB
 SANOFI PASTEUR
 uk168ab
Injection site pain, Injection site swelling, Injection site warmth Injection site pain, Injection site swelling, Injection site warmth
Per guardian: Pain at injection site, warm to touch, lumped area. Per guardian: Pain at injection site, warm to touch, lumped area.
2830699 80 F NY 03/11/2025 PNC21
 MERCK & CO. INC.
 Y019157
Pain, Pain in extremity Pain, Pain in extremity
patient says shooting pain in arm approximately one hour after vaccination patient says shooting pain in arm approximately one hour after vaccination
2830700 16 M AL 03/11/2025 MNQ
MNQ
 SANOFI PASTEUR
SANOFI PASTEUR
 U8193AB
U8193AB
Balance disorder, Feeling hot, Hyperhidrosis, Loss of consciousness, Pallor; Syn... Balance disorder, Feeling hot, Hyperhidrosis, Loss of consciousness, Pallor; Syncope More
Patient had a vasovagal syncopal episode following MCV4 vaccination; no injury was sustained to pati... Patient had a vasovagal syncopal episode following MCV4 vaccination; no injury was sustained to patient. Ten minutes post vaccination patient stood up from chair, walked toward the door and stated "It's hot in here may I step out to get some air". Then patient turned pale, started to sweat, and started to appear unsteady on his feet. Patient was assisted to a chair before losing consciousness and monitored closely for 30 minutes; patient lost consciousness for approximately 30 seconds. Patient denied further symptoms after 30 minute monitoring. Vital signs at discharge: blood pressure 122/80, heart rate 70, respirations 16. Discharged patient with sibling; patient was alert and oriented X 4 at discharge. More
2830701 1.25 F AZ 03/11/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 4T93R
No adverse event No adverse event
No adverse event, PCP advised. PCP notified parents spoke with them during office visit and answered... No adverse event, PCP advised. PCP notified parents spoke with them during office visit and answered any questions/concerns they may have. More
2830702 1 F TX 03/11/2025 VARCEL
 MERCK & CO. INC.
 Y015557
Contraindication to vaccination Contraindication to vaccination
Patient came in today for lab appt. to receive Varicella vaccine since she was told we were out of t... Patient came in today for lab appt. to receive Varicella vaccine since she was told we were out of the vaccine when she was here for an appt. on 03/05/25. I ordered the vaccine today since I remembered she did not receive it last week. Dr came into my office to ask if she had already received the vaccine today because she wasn?t supposed to receive it today because she received the MMR vaccine last week. Dr and I went to look for MA who was going to give the vaccine, but she walked out of the pt room at that time and stated she had just administered the vaccine. I spoke with mom and informed her that she should not have received the vaccine today and that was my mistake for ordering it. I was not aware that if both vaccines were not given on the same day, there had to be a 30 day waiting period in between live virus vaccines. Per Dr, patient will receive the Varicella vaccine again at next WCC which is age 15 months. More
2830703 50 M MT 03/11/2025 PNC20
 PFIZER\WYETH
Proctitis ulcerative Proctitis ulcerative
Fever up to 102.8 since 11pm last night. Fatigue. Still have fever on 3/11 3pm mst. Symptoms are ... Fever up to 102.8 since 11pm last night. Fatigue. Still have fever on 3/11 3pm mst. Symptoms are not improving. Feel horrible More
2830704 0.33 M MA 03/11/2025 DTAPIPVHIB
 SANOFI PASTEUR
Single component of a two-component product administered Single component of a two-component product administered
Incomplete administration of Pentacel- Hib not given in administration. When preparing vaccine only ... Incomplete administration of Pentacel- Hib not given in administration. When preparing vaccine only 1 part of the 2 parts reconstitute vaccine was prepared and given to patient. More
2830706 51 F MD 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 N35N9
Injection site cellulitis, Injection site erythema Injection site cellulitis, Injection site erythema
(1) Cellulitis: L03.90 - Cellulitis, unspecified Plan: acute, uncontrolled In setting of ... (1) Cellulitis: L03.90 - Cellulitis, unspecified Plan: acute, uncontrolled In setting of shingles vaccine, though not at injection site, but a few inches below site. start doxycycline 100mg BID x7days New markings drawn, patient will call if redness continues to spread after 3-4days on antibiotic. Medications: New doxycycline hyclate 100 mg PO BID 7 days 14 caps 0RF More
2830707 80 M CA 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3G33K
Mobility decreased, Muscular weakness, Walking aid user Mobility decreased, Muscular weakness, Walking aid user
About 24 hrs later experienced serious loss of strength and mobility of lower limbs. Needed walker t... About 24 hrs later experienced serious loss of strength and mobility of lower limbs. Needed walker to get from bed to bathroom. Symptoms lessened each day but it took four days for mobility to visit doctor. He noted strength and mobility returning and suggested rest and mild exercise. Within a month I was perhaps 70-percent recovered; within several months, 90-percent. Two mild recurrences: one during UTI infection and antibiotics; the other weakness in left knee treated with rest. I understand that recurrences might continue. Thus I mark "Unknown" below More
2830708 74 F VA 03/11/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Y019158
Y019158
Blood pressure increased, Heart rate increased, Injection site erythema, Injecti... Blood pressure increased, Heart rate increased, Injection site erythema, Injection site pruritus, Injection site swelling; Injection site warmth, Sleep disorder More
PATIENT STATES THAT SYMPTOMS STARTED AROUND 2AM ON 03/08/25. PATIENT STATED UNABLE TO SLEEP DUE TO S... PATIENT STATES THAT SYMPTOMS STARTED AROUND 2AM ON 03/08/25. PATIENT STATED UNABLE TO SLEEP DUE TO SORE ARM, REDNESS AROUND INJECTION SITE/, REDNESS AROUND UPPER ARM, ITCHING, SWOLLEN, WARM TO TOUCH. PATIENT ALSO STATES OF INCREASED BLOOD PRESSURE AND HEART RATE More
2830709 23 F WI 03/11/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EL3249
EL3249
Biopsy, Computerised tomogram, Immune system disorder, Laboratory test, Magnetic... Biopsy, Computerised tomogram, Immune system disorder, Laboratory test, Magnetic resonance imaging; Rash, Thrombosis, Ultrasound scan More
Destroyed immune system, recurring rashes, and had 4 blood clots. Destroyed immune system, recurring rashes, and had 4 blood clots.
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2830710 86 F FL 03/11/2025 PNC20
 PFIZER\WYETH
 LK6650
Erythema, Skin warm Erythema, Skin warm
Patients arm is red all over (top half of arm) and warm to touch Patients arm is red all over (top half of arm) and warm to touch
2830711 73 M AZ 03/11/2025 COVID19
 PFIZER\BIONTECH
Anaphylactic reaction, Blood pressure measurement, Hypotension, Loss of consciou... Anaphylactic reaction, Blood pressure measurement, Hypotension, Loss of consciousness, Rash erythematous More
Anaphylactic; he passed out.; the next day woke up from the neck down with a big red rash; a full bo... Anaphylactic; he passed out.; the next day woke up from the neck down with a big red rash; a full body rash.; Blood pressure was low, 90/45.; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Nov2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 73 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing); "Pulse abnormal" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal, pulse abnormal, start date: 2023 (ongoing); ATORVASTATIN taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (Dose number unknown, single; previous vaccines he had little reactions; just got minor chills and fever), for Covid-19 immunization, reaction(s): "minor chills", "fever"; Bnt162b2 (Dose number unknown, single; he missed one booster and got covid Jul2024 and was pretty sick), for Covid-19 immunization, reaction(s): "Covid". The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 22Nov2024, outcome "recovered" (Nov2024), described as "Anaphylactic"; HYPOTENSION (medically significant) with onset 22Nov2024, outcome "recovered" (Nov2024), described as "Blood pressure was low, 90/45."; LOSS OF CONSCIOUSNESS (medically significant) with onset 22Nov2024, outcome "recovered" (22Nov2024), described as "he passed out."; RASH ERYTHEMATOUS (medically significant) with onset 22Nov2024, outcome "recovered" (Nov2024), described as "the next day woke up from the neck down with a big red rash; a full body rash.". Clinical course: Patient started Metoprolol and Atorvastatin about 2 or 3 years ago and still taking. Patient first stated when he got the shot it was no big deal. He has gotten all the covid vaccines. He always had covid vaccine from Pfizer. With previous vaccines, he had little reactions. Haven't had anything go bad, just got minor chills and fever. Rash occurred the day after injection (22Nov2024): woke up from the neck down with a big red rash; a full body rash. Called the doctor where patient got the shot at and was told to come in. When the patient got there, he passed out. They called the paramedics. Patient got right up, wasn't passed out for long. Blood pressure was low, 90/45. It was recommended to go to the hospital. Was told it sounds like a reaction to the vaccine. Patient went to the emergency room, and they gave him an anaphylactic IV, within a matter of 20 minutes or so the rash started to clear up. Vitals went back to normal. Kept patient there for 4 hours just to make sure the IV was not going to have any adverse effects and was sent home. Within 12-14 hours, the rash was completely gone. Patient was sent home with epi pen just in case, because could possibly come back and it never did. It's now been almost 6 months. Besides reporting event, patient stated he is going to the allergist to see what he is allergic to in vaccine and would like a list of ingredients for the vaccine. The information on the batch/lot number for Bnt162b2 Omicron (KP.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500052878 same patient, different dose number/event;US-PFIZER INC-202500052876 same patient, different dose number/event; More
2830712 66 F MD 03/11/2025 PNC20
 PFIZER\WYETH
 LJ5284
Cough, Dyspnoea, Hypoaesthesia, Pericardial effusion, Pleural effusion Cough, Dyspnoea, Hypoaesthesia, Pericardial effusion, Pleural effusion
Fluid building around her heart goes hand with breathing; Coughing; Difficulty breathing; face numbn... Fluid building around her heart goes hand with breathing; Coughing; Difficulty breathing; face numbness; This is a spontaneous report received from a Pharmacist. A 67-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Feb2025 as dose number unknown, 0.5 ml, single (Lot number: LJ5284) at the age of 66 years intramuscular, in left deltoid for immunisation; budesonide, formoterol fumarate (SYMBICORT) at 2 DF 2x/day (2 df, 2x/day (2 puffs twice a day)) for respiratory disorder. The patient's relevant medical history included: "COPD" (ongoing); "Blood pressure high" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "chest pain" (unspecified if ongoing); "circulation around heart" (unspecified if ongoing); "wheezing" (unspecified if ongoing); "mild heart failure" (ongoing), notes: pre-existing condition with her heart, like heart failure. Concomitant medication(s) included: LOSARTAN oral taken for hypertension (ongoing); ROSUVASTATIN oral taken for blood cholesterol increased; EZETIMIBE oral taken for blood cholesterol abnormal (ongoing); ISOSORBIDE MONONITRATE oral taken for cardiovascular disorder, chest pain (ongoing); ALBUTEROL HFA taken for wheezing (ongoing). The patient also took other concomitant therapy which included "eye drops" (as reported). The following information was reported: DYSPNOEA (disability) with onset 11Feb2025, outcome "recovering", described as "Difficulty breathing"; HYPOAESTHESIA (medically significant) with onset 11Feb2025, outcome "recovering", described as "face numbness"; PERICARDIAL EFFUSION (medically significant), outcome "unknown", described as "Fluid building around her heart goes hand with breathing"; COUGH (non-serious), outcome "unknown", described as "Coughing". The events "difficulty breathing", "face numbness" and "fluid building around her heart goes hand with breathing" required physician office visit. The action taken for budesonide, formoterol fumarate was dosage reduced. Therapeutic measures were taken as a result of dyspnoea, hypoaesthesia, pleural effusion. Clinical course: The reporter has a patient that is a medication therapy management patient. It was recommended for the patient to be immunized. She confirmed she did not give it, and the patient got it at the doctor's office. The patient reported some concerning side effects. Clarified events as the patient has had difficulty breathing. She has a pre-existing condition with her heart, like heart failure. She has a fluid feeling around her heart. She also experienced face numbness. Difficulty Breathing: Fluid building around her heart goes hand with breathing (as reported). She saw the doctor about it on 20Feb2025 and had course of Prednisone and Azithromycin Z Pack. She also was given a cough suppressant, Benzonatate 100mg. She also experienced coughing. She added, she takes Symbicort inhaler for breathing anyways. However, normally she takes 2 puffs twice a day. On her own she has cut from taking 2 puffs twice a day to 1 puff twice a day. When she did this her breathing and facial numbness got better. She wanted to see if this is something that has been reported in the past, related, or documented previously. Relatedness of vaccine to events Dyspnoea, Hypoaesthesia and Cough was reported as Unknown (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection).; Sender's Comments: The events dyspnoea, and hypoaesthesia are conservatively assessed as related to the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. As there is limited information in the case provided, the causal association between the event pleural effusion and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
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2830713 16 M MN 03/11/2025 COVID19
 PFIZER\BIONTECH
 ER8731
Deep vein thrombosis, Peripheral artery thrombosis Deep vein thrombosis, Peripheral artery thrombosis
blood clots in my popliteal vein and lower limbs; blood clots in my popliteal vein and lower limbs; ... blood clots in my popliteal vein and lower limbs; blood clots in my popliteal vein and lower limbs; This is a spontaneous report received from a Consumer or other non HCP. A 20-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Lot number: ER8731) at the age of 16 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: Ep7534), administration date: 19Mar2021, when the patient was 16-year-old, for COVID-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant), PERIPHERAL ARTERY THROMBOSIS (hospitalization) all with onset 11Feb2025, outcome "recovering" and all described as "blood clots in my popliteal vein and lower limbs". Therapeutic measures were taken as a result of deep vein thrombosis, peripheral artery thrombosis included Eliquis. Clinical course: 3 weeks ago, the patient was diagnosed with blood clots in his popliteal vein and lower limbs. More
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2830714 62 F VA 03/11/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure
diagnosed with COVID; diagnosed with COVID; The initial case was made invalid due to No adverse effe... diagnosed with COVID; diagnosed with COVID; The initial case was made invalid due to No adverse effect. Upon receipt of follow-up report on 15Feb2024, this case now contains all required information to be considered valid. This is a spontaneous report and received from Consumer or other non HCPs, Program ID. A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: high blood pressure; "asthmatic" (unspecified if ongoing); "different forrns of Arthritis" (unspecified if ongoing); "neuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Feb2024, outcome "unknown" and all described as "diagnosed with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as patient being treated with Paxlovid. Clinical course: The patient was just diagnosed this past Tuesday with COVID (13Feb2024). It was her first time having it, she's one of the patients that have underlying conditions such as high blood pressure (hypertension), asthmatic and diabetes. She have been getting the Covid Shots up until her insurance ran out in October of last year (Oct2023). The patient stated,"I have asthma, I have diabetes, and I have hypertension. I do have a form of Arthritis. Some Arthritis, (inaudible) it's called neuropathy(inaudible), so I'm all messed up with those (inaudible)". More
2830715 M TX 03/11/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Biopsy lymph gland, Blood culture, C-reactive protein, Chest X-ray, Computerised... Biopsy lymph gland, Blood culture, C-reactive protein, Chest X-ray, Computerised tomogram neck; Culture, Immune reconstitution inflammatory syndrome associated tuberculosis, Interferon gamma release assay, Investigation, Red blood cell sedimentation rate; Serology test More
antitumor-necrosis-factor-alphainduced tuberculosis-associated IRIS; This is a literature report for... antitumor-necrosis-factor-alphainduced tuberculosis-associated IRIS; This is a literature report for the following literature source(s). A 47-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's concomitant medications were not reported. The following information was reported: IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME ASSOCIATED TUBERCULOSIS (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "recovered", described as "antitumor-necrosis-factor-alphainduced tuberculosis-associated IRIS". The patient with no past medical history developed pain and weakness in his inter-phalangeal and metacarpal-phalangeal joints. On the basis of his symptoms, laboratory testing, and imaging of his hands, he was diagnosed with seronegative rheumatoid arthritis. He was started on biologic treatment with anti-TNF agent adalimumab and methotrexate. Before starting treatment, he had a chest X-ray, which was normal and a test for M. tuberculosis using an interferon gamma release assay, which was also negative. He received two doses of Pfizer mRNA vaccine 4 weeks apart without any complications. Then, 6 months after starting adalimumab, he developed constitutional symptoms including headaches, nocturnal sweats, and low-grade fever. He then developed neck pain and was noted to have bilateral cervical adenopathy noted on exam. Computed tomography (CT) scan of the neck confirmed bilateral cervical adenopathy. His immunosuppressive therapy was stopped. A cervical lymph node biopsy was performed. The histology results were strongly positive for acid-fast bacilli. A diagnosis of tuberculous lymphadenitis was made, and he was started on a four-drug regimen with Isoniazid, Rifampin, Pyrazinamide and Ethambutol. Within 5 days of starting the regimen, he noted a significant improvement in his symptoms. The mycobacterial cultures revealed that the bacillus was susceptible to all the antituberculous drugs. About 2 weeks after starting his antitubercular therapy, he received a dose of previously scheduled COVID mRNA vaccine (third dose of Pfizer mRNA), and 5 days after receiving the vaccine, he developed severe constitutional symptoms including fever, chills, and excessive diaphoresis. He was admitted to the hospital for further evaluation. His exam was unremarkable for any new finding. He was ruled out for sepsis with negative blood cultures and serological testing. Inflammatory markers including ESR and C-reactive protein (CRP) were elevated at 35 mm/hour and 5.33 mg/l. He was diagnosed with antitumor-necrosis-factor-alpha-induced tuberculosis-associated IRIS. Treatment was started with intravenous methylprednisolone 80 mg every 8 hours, with resolution of his symptoms. He was transitioned to oral prednisolone 100 mg twice a day and discharged home 5 days later. His oral steroids were gradually weaned off over the next 3 months. He finished a 12-month course of antitubercular therapy. He had had no recurrent symptoms at 18-month follow-up and was discharged from the infectious disease clinic. He was able to resume therapy with adalimumab after 4 months of antitubercular therapy. The diagnosis of TB-IRIS is based on initial improvement of TB-related symptoms with initiation of TB therapy, paradoxical deterioration of TB related symptoms during TB therapy, and exclusion of other possible causes of clinical deterioration. This patient fulfilled all these criteria. His immune response after receiving COVID vaccine booster may have further contributed to activation of his immune system, resulting in presentation with IRIS. Immune reconstitution inflammatory syndrome should be considered as a differential in patients who develop paradoxical worsening of symptoms with antitubercular therapy in the setting of immune reconstitution. Hyperactive immune response after infection or messenger ribonucleic acid vaccine booster may have contributed to the development of immune reconstitution inflammatory syndrome syndrome in this patient.; Sender's Comments: The event immune reconstitution inflammatory syndrome associated tuberculosis is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
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2830716 56 F WA 03/11/2025 PNC20
 PFIZER\WYETH
 ln4927
Headache, Paraesthesia Headache, Paraesthesia
headache and left side of face started to tingle headache and left side of face started to tingle
2830717 0.33 M KS 03/11/2025 RV5
 MERCK & CO. INC.
 Y005907
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Gave first dose of Rotavirus at 4months old. No adverse events. Gave first dose of Rotavirus at 4months old. No adverse events.
2830718 29 F WA 03/11/2025 COVID19
 MODERNA
 3043823
Expired product administered, No adverse event Expired product administered, No adverse event
Patient did not have any adverse reactions to the vaccine. Patient was given a dose that had a BUD ... Patient did not have any adverse reactions to the vaccine. Patient was given a dose that had a BUD of 02/14/2025 and the vaccine was given on 02/17/2025. More
2830719 61 F CA 03/11/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 P100713527
P100713527
Bradycardia, Burning sensation, Dizziness, Immediate post-injection reaction, Pa... Bradycardia, Burning sensation, Dizziness, Immediate post-injection reaction, Pain in jaw; Trismus More
Patient felt a burning sensation upon receiving the vaccine immediately after felt dizziness, brady... Patient felt a burning sensation upon receiving the vaccine immediately after felt dizziness, bradycardia & jaw felt sore & locked - patient felt better after being monitored by MA & Provider after 1hr of monitoring vitals & EKG- patient was given water & a Ammonia ampule was used due to patient feeling faint. More
2830720 27 F WA 03/11/2025 ANTH
 EMERGENT BIOSOLUTIONS
Bladder discomfort, Culture urine negative, Cystitis interstitial, Dysuria, Urin... Bladder discomfort, Culture urine negative, Cystitis interstitial, Dysuria, Urine analysis normal More
Bladder discomfort, painful urination at the end of stream, no other symptoms. Bladder discomfort, painful urination at the end of stream, no other symptoms.
2830737 26 M WA 03/11/2025 COVID19
 MODERNA
 3043823
Expired product administered, No adverse event Expired product administered, No adverse event
Pt did not have any adverse reactions to the vaccine. Pt was given a vaccine that had a BUD: 02/14/2... Pt did not have any adverse reactions to the vaccine. Pt was given a vaccine that had a BUD: 02/14/2025 and vaccine was given on 02/19/2025. More
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